Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 85293 

fusion or other rearrangement as 

detected by an FDA-approved test. This 

indication is approved under 

accelerated approval based on overall 

response rate and duration of response. 

Continued approval for this indication 

may be contingent upon verification and 

description of clinical benefit in 

confirmatory trial(s). Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

Truseltiq (U.S. Patent No. 8,552,002) 

from QED Therapeutics, Inc. (agent of 

Novartis AG), and the USPTO requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated January 18, 

2023, FDA advised the USPTO that this 

human drug product had undergone a 

regulatory review period and that the 

approval of Truseltiq represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

USPTO requested that FDA determine 

the product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

Truseltiq is 4,258 days. Of this time, 

4,016 days occurred during the testing 

phase of the regulatory review period, 

while 242 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: October 2, 

2009. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on October 2, 2009. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: September 29, 2020. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

Truseltiq (NDA 214622) was initially 

submitted on September 29, 2020. 

3. The date the application was 

approved: May 28, 2021. FDA has 

verified the applicant’s claim that NDA 

214622 was approved on May 28, 2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,516 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: December 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26885 Filed 12–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–3539] 

Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Interim 

Policy on Compounding Using Bulk 

Drug Substances Under section 503B of 

the Federal Food, Drug, and Cosmetic 

Act’’ (draft guidance or 2023 503B 

Interim Policy Draft Guidance) to 

describe FDA’s interim policy regarding 

the use of bulk drug substances in 

compounding by outsourcing facilities 

while FDA develops the list of bulk 

drug substances that outsourcing 

facilities can use in compounding under 

the applicable section of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). This draft guidance, when 

finalized, will replace the guidance for 

industry entitled, ‘‘Interim Policy on 

Compounding Using Bulk Drug 

Substances Under section 503B of the 

Federal Food, Drug, and Cosmetic Act’’ 

issued in January 2017 (2017 503B 

Interim Policy Guidance). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 8, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 


ddrumheller on DSK120RN23PROD with NOTICES1
85294 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 

1FDA recognizes that some compounders and 

other stakeholders may currently be in the process 

of compiling a nomination for the 503B bulks list 

for submission to the Agency. FDA intends to 

categorize nominations of bulk drug substances 

received prior to the date in which FDA announces 

the availability of the final guidance. FDA believes 

that this will provide a sufficient amount of time 

in which to submit nominations that are currently 

in progress. 

2015–D–3539 for ‘‘Interim Policy on 

Compounding Using Bulk Drug 

Substances Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Rechelle Buford, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 240–402–0447. 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act.’’ This draft guidance, 

when finalized, will replace the 2017 

503B Interim Policy Guidance, available 

at https://www.fda.gov/media/94402/ 

download. 

Section 503B of the FD&C Act (21 

U.S.C. 353b) describes the conditions 

that must be satisfied for human drug 

products compounded by an 

outsourcing facility to be exempt from 

the following three sections of the FD&C 

Act: (1) section 505 (21 U.S.C. 355) 

(concerning the approval of drugs under 

new drug applications or abbreviated 

new drug applications); (2) section 

502(f)(1) (21 U.S.C. 352(f)(1) (concerning 

the labeling of drugs with adequate 

directions for use); and (3) section 582 

(21 U.S.C. 360eee–1) (concerning drug 

supply chain security requirements). 

One of the conditions that must be met 

for a drug product compounded by an 

outsourcing facility to qualify for these 

exemptions is that the outsourcing 

facility does not compound a drug using 

a bulk drug substance unless: (1) the 

bulk drug substance appears on a list 

established by the Secretary of Health 

and Human Services identifying bulk 

drug substances for which there is a 

clinical need (the 503B bulks list) (see 

section 503B(a)(2)(A)(i)) or (2) the drug 

compounded from such bulk drug 

substances appears on the drug shortage 

list in effect under section 506E of the 

FD&C Act (21 U.S.C. 356e) at the time 

of compounding, distribution, and 

dispensing (see section 503B(a)(2)(A)(ii) 

of the FD&C Act). 

This draft guidance, when finalized, 

will revise FDA’s current interim policy 

with respect to categorization of certain 

substances nominated for inclusion on 

the 503B bulks list. The guidance, when 

finalized, would end the categorization 

of bulk drug substances into Categories 

1, 2, or 3 for those bulk drug substances 

nominated on or after the date of 

publication of the final guidance. 

The 2017 503B Interim Policy 

Guidance describes the conditions 

under which FDA does not intend to 

take action against an outsourcing 

facility for compounding a drug using 

certain bulk drug substances that are not 

eligible for use in compounding under 

section 503B because they do not appear 

on the 503B bulks list and that are not 

used to compound a drug that appears 

on the FDA drug shortage list at the time 

of compounding, distribution, and 

dispensing. One of those conditions is 

that the bulk drug substance appears in 

Category 1. If the 2023 503B Interim 

Policy Draft Guidance is finalized in its 

current form, a substance nominated on 

or after the date of publication of that 

final guidance would not be categorized 

and would not be within the scope of 

the policy for substances that appear in 

Category 1.1 However, FDA would 

consider the substance for inclusion on 

the 503B bulks list in accordance with 

the process and clinical need standard 

established in the FD&C Act (see section 

503B(a)(2)(A)(i) of the FD&C Act). 

Substances that already appear in 

Category 1 (including substances 

nominated with adequate supporting 

information prior to the date of 

publication of the final guidance) may 

continue to be eligible for the policy 

that applies to Category 1 substances, as 

described in the final guidance, until 

FDA makes a final determination 

whether they will be placed on the 503B 

bulks list in accordance with section 

503B(a)(2)(A)(i) of the FD&C Act or 

unless the Agency removes the 

substances from Category 1 based on, for 

example, information about safety risks. 

FDA encourages interested parties to 

focus their comments on the limited 

revisions to the interim policy included, 

for public comment, in the 2023 503B 

Interim Policy Draft Guidance. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the ‘‘Interim Policy on Compounding 

Using Bulk Drug Substances Under 

Section 503B of the Federal Food, Drug, 

and Cosmetic Act.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 85295 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26845 Filed 12–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3462] 

Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs.’’ The guidance 

addresses the verification systems that 

manufacturers, repackagers, wholesale 

distributors, and dispensers must have 

in place to comply with the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Drug Supply 

Chain Security Act (DSCSA). 

Specifically, the guidance covers the 

statutory verification systems 

requirements that include the 

quarantine and investigation of a 

product determined to be suspect and 

the quarantine and disposition of a 

product determined to be illegitimate. 

The guidance also addresses the 

statutory requirement for notification to 

the Agency of a product that has been 

cleared by a manufacturer, repackager, 

wholesale distributor, or dispenser (also 

referred to as ‘‘trading partners’’) after a 

suspect product investigation because it 

is determined that the product is not an 

illegitimate product. Finally, the 

guidance addresses the statutory 

requirement for responding to requests 

for verification and processing saleable 

returns. The guidance finalizes the 

revised draft guidance ‘‘Verification 

Systems Under the Drug Supply Chain 

Security Act for Certain Prescription 

Drugs,’’ issued on March 10, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 7, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–3462 for ‘‘Verification Systems 

Under the Drug Supply Chain Security 

Act for Certain Prescription Drugs; 

Guidance for Industry; Availability.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https:// 

www.govinfo.gov/content/pkg/FR-2015-

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or to Office of Communication, 

Outreach and Development, Center for 


ddrumheller on DSK120RN23PROD with NOTICES1